Kadmon updates 'positive' results from Phase 2 study of KD025 in cGVHD
Kadmon announced updated "positive" results from an ongoing Phase 2 clinical trial evaluating KD025, its Rho-associated coiled-coil kinase 2 inhibitor, in patients with chronic graft-versus-host disease. The results are being presented in an oral presentation at the BMT Tandem Meetings in Salt Lake City. Updated data from Cohort 2 of the trial showed an Overall Response Rate of 69%. Responses in Cohort 1 remained the same, showing an ORR of 65%. Responses were rapid, with approximately 70% of patients across Cohorts 1 and 2 achieving responses after 8 weeks of treatment. Responses were observed across all affected organs. 64% of patients were able to reduce steroid dose, and four patients completely discontinued steroid use. KD025 was well tolerated, with no drug-related serious adverse events in either cohort. Kadmon expects to enroll an expansion cohort of approximately 40 patients after the optimal dose has been determined. In October 2017, KD025 received orphan drug designation from the FDA for cGVHD.